AstraZeneca Pharmaceuticals LP Regulatory Manager in Waltham, Massachusetts

Regulatory Manager

At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the utmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

Description

As the Regulatory Manager you will be responsible for all areas of the local animal regulatory process. You will ensures compliance with requirements from local regulatory agencies. The Regulatory Manager will also work as a partner within relevant therapeutic area and project teams providing regulatory intelligence and advice, and strategic input, as appropriate. You will implement strategies to improve quality and efficiency of submissions. You may serve as a people manager of LAS scientists.

Typical Accountabilities:

  • Administration of the local oversight body, including the scheduling of meetings, preparation of meeting agendas and minutes, maintaining electronic documents and records, and serving as an expert in software systems utilized to support the oversight body operation.

  • Key customer-facing role providing end-to-end support for internal and external studies with regard to regulatory compliance and adherence to Company standards and policies.

  • Works with compliance colleagues to define and deliver training for personnel.

  • Oversees risk assessment and management of 3rd party interactions. May conduct virtual and onsite audits of 3rd party facilities and programs.

  • Operationally manages and executes “second line of defence” accountabilities (including conduct of monitoring activities, support for auditing, investigations, assurance reporting etc.).

  • Delivers regional communications strategies to ensure visibility of and promote compliance with regulatory requirements and Company standards.

  • May support project groups and/or cross-functional teams for complex regulatory applications.

  • Builds networks and processes to ensure that learnings from own projects are shared with other colleagues within the department and other relevant project teams.

  • May design and execute investigative studies pertaining to the 3Rs and improving animal welfare. Leads or contributes to scientific communication, promoting AstraZeneca through posters, presentations and publications.

  • Be ambassador of local and global Culture of Care. Will drive community and animal research awareness initiatives.

  • If working as a line manager, the expectations are:

  • Ensure staff are trained appropriate to ensure all animal activities is conducted at the highest standard.

  • Ensures own work, and the work of others, is performed in accordance with appropriate SHE, quality and compliance standards.

  • Organize and plan the workload of the team.

  • Lead and manage the performance and development of staff by agreeing and contributing to clear objectives and development targets. Conduct regular reviews, ensuring staff are well managed, motivated, and productive in accordance with the highest professional standards. Provides regular updates on team performance to senior management.

  • Provides leadership and identifies current and future capability requirements for team members, ensures people and resources are managed and allocated effectively to ensure department objectives are met.

  • Anticipates and resolves cross team problems offering solutions and managing risk.

  • Supports company and department on-going changes. Key role in performing risk management and business continuity evaluations. May be requested to assist in disaster planning and execution of plan in the event of an emergency.

Essential Requirements

  • BSc (for US) / MSc (for Europe)

  • Thorough knowledge of the animal experimentation regulatory approval process

  • Expertise in information and document management technology

  • Experience working with cross-functional project teams

  • Deep understanding of current laboratory animal regulatory environment

  • Will require a good knowledge and understanding of any relevant local legislation.

Preferred Requirements

  • Knowledge of pharmaceutical business and processes

  • Excellent negotiation skills

  • Experience of project management

  • Experience of facility auditing

Key Internal Relationships

  • Members of project teams

  • Veterinary and compliance colleagues

  • Licensees and scientists

  • Holders of statutory functions

  • Ethical review bodies

  • Operations function

Key External relationships

  • Regulatory bodies

  • 3rd party suppliers

  • Scientific collaboration partners

  • National or international organizations in Animal Legislation and Animal Welfare

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we're more than one of the world's leading pharmaceutical companies. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives and are made to feel valued, energized and rewarded for their ideas and creativity.

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.